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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bottle, Collection, Vacuum
510(k) Number K851892
Device Name COMPACT 2000
Applicant
Atrium Medical Corp.
10 Northern Blvd.
Amherst,  NH  03031
Applicant Contact STEVE HERWECK
Correspondent
Atrium Medical Corp.
10 Northern Blvd.
Amherst,  NH  03031
Correspondent Contact STEVE HERWECK
Regulation Number880.6740
Classification Product Code
KDQ  
Date Received04/30/1985
Decision Date 06/14/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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